Rod, Fixation, Intramedullary and Accessories

How Is HSB Classified?

Rod, Fixation, Intramedullary And Accessories is FDA product code HSB, Class 2, 21 CFR 888.3020.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 12 clearances under this code; the FDA took a median of 257 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 690 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Process change control (67), Employee error (67) and Process control (61).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.